The purpose of this study is to find the right dose of two medications, oliceridine and propofol, when used together for sedation in patients with obesity undergoing a painless gastroscope procedure. Currently, standard sedation methods using other opioids can sometimes cause breathing problems, especially in patients with obesity. Oliceridine is a newer medication that may provide good pain relief with a lower risk of these side effects. However, the best dose of propofol when combined with oliceridine for this specific patient group is not yet clear. This study will enroll patients with obesity (BMI ≥ 28 kg/m²) who are scheduled for a routine painless gastroscopy. Participants will receive the study medications during their procedure, and the medical team will carefully monitor their vital signs and sedation level. The study aims to find the most effective and safe dose combination to help guide future clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Oliceridine at a low fixed dose is administered intravenously, followed by propofol at an initial dose of 2 mg/kg based on lean body weight.
Oliceridine at a high fixed dose is administered intravenously, followed by propofol at an initial dose of 1.5 mg/kg based on lean body weight.
Effective Dose (ED50 and ED95) of Propofol Combined with Oliceridine for Gastroscope Insertion
The ED50 and ED95 of propofol (based on lean body weight) required to achieve successful sedation during gastroscope insertion, estimated using the biased coin design up-and-down method with isotonic or central ordered regression. Positive response is defined as: cough or body movement ≥ grade 2 during gastroscope insertion, requiring additional propofol.
Time frame: Within 3 minutes after gastroscope insertion
Time to Loss of Consciousness
Time from initiation of propofol administration to loss of consciousness, defined as MOAA/S score ≤ 1.
Time frame: Within 5 minutes
Procedure Duration
Total time from gastroscope insertion to completion of the endoscopic examination.
Time frame: Periprocedural
Recovery Time
Time from the end of the initial propofol dose administration to the first of three consecutive MOAA/S scores of 5, indicating full alertness.
Time frame: Within 30 minutes post-procedure
Total Propofol Dose
Total dose of propofol administered during the entire procedure, including the initial dose and any rescue boluses.
Time frame: Periprocedural
Incidence of Adverse Events
(1) Respiratory depression: SpO₂ \< 90% despite oxygen supplementation after relief of upper airway obstruction, or absence of spontaneous breathing; (2) Hypotension: mean arterial pressure (MAP) decrease \> 20% from pre-sedation baseline, or systolic blood pressure ≤ 90 mmHg, from drug administration until discharge from the post-anesthesia care unit; (3) Bradycardia: heart rate \< 50 beats per minute.
Time frame: From drug administration to PACU discharge
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